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在免疫检查点阻塞的试验与常规护理高级泌尿腺癌患者的生存率进行比较
Lucy S Wang1, Rebecca A Hubbard2, Ronac Mamtani3
1Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Pharmacoepidemiology and drug safety
|April 29, 2024
概括
使用 pembrolizumab 的一线免疫疗法在常规护理和临床试验中的晚期泌尿腺癌 (aUC) 患者的整体存活率相似. 这种现实世界的有效性为接受免疫检查点抑制剂的西斯普拉丁不合格患者提供了保证.
科学领域:
- 在瘤学瘤学.
- 免疫治疗是一种免疫疗法.
- 尿路细胞癌是什么意思
背景情况:
- 晚期泌尿腺癌 (aUC) 的治疗选择已经扩大到免疫检查点抑制剂.
- 临床试验中的一线免疫疗法的有效性可能无法完全转化为现实世界的有效性.
- 有限的数据存在于接受pembrolizumab.com的西斯普拉丁不合格的aUC患者的现实世界结果.
研究的目的:
- 在接受一线 pembrolizumab 在常规护理中的晚期泌尿腺癌 (aUC) 患者之间比较整体存活率 (OS),与 KEYNOTE-052 临床试验相比.
- 评估pembrolizumab单一治疗在不符合cisplatin治疗条件的aUC患者中的实际有效性.
主要方法:
- 追溯队列研究比较常规护理患者 (Flatiron Health数据库) 与KEYNOTE-052试验参与者.
- 经匹配调整的间接比较被用于平衡队列之间的患者特征.
- 来自KEYNOTE-052试验的资格标准被应用来构建常规护理队列.
主要成果:
- 常规护理队列年龄较大,女性更多,并且由于功能障碍,更频繁地不符合cisplatin的条件.
- 在加权的常规护理队列中,中位数的生存期为9个月,而在试验队列中为11.3个月.
- 在Kaplan-Meier OS曲线中没有发现显著差异 (p=0.76),在12,24和36个月的生存概率相似.
结论:
- 用 pembrolizumab 进行一线免疫疗法显示,在不接受 cisplatin 治疗的晚期尿路细胞癌 (aUC) 患者的常规护理中,其效果与临床试验中观察到的效果相似.
- 现实世界的数据支持在这个患者群体中使用pembrolizumab.
- 这些发现为日常临床实践中免疫治疗的好处提供了保证.
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